SBM 06 - Blood pressure monitor SANITAS - Free user manual and instructions

USER MANUAL SBM 06 SANITAS

You can measure your blood pressure quickly and easily with the blood pressu- re wrist computer, save the readings – and display the progress and average of the readings. The wrist blood pressure monitor is used for non-invasive measu- rement and monitoring of adults´arterial blood pressure. The computer complies with the requirements of the European Directive for Medical Products, the German Medical Product Act as well as the European14 standards EN1060-1 (Non-invasive blood pressure measuring devices Part 1: General requirements) EN1060-3 (Non-invasive blood pressure measuring devices

Part 3: Supplementary requirements for electromechanical blood pressure measu-

ring systems). Regular checks on measuring accuracy are necessary according to the “Directive for users of medical products” when the computer is used for indu- strial or commercial purposes. For private use also, we recommend that you have the measuring accuracy checked by the manufacturer at 2-yearly intervals. Keep these operating instructions available for further use and also make them available to other users.

2. Caution – For Your Safety!

• Always measure your blood pressure at the same time of day in order to ensure comparability of the readings.

• Relax for about 3 – 5 minutes before every measurement.

• Wait 5 minutes between successive measurements.

• The measurements you make yourself are only for your information – they are no substitute for a medical examination! Discuss your readings with your doctor and on no account make your own medical decisions (e.g. drugs and their dosages).

• The wrist measurement will be less accurate if an arm suffers from restric ted blood circulation resulting from chronic or acute vascular diseases (including vasoconstrictions). In this case, use a sphygmomanometer for measurements on the upper arm.

• Measuring errors can occur in diseases of the cardiovascular system, as well as with very low blood pressure, irregular blood circulation and arrhythmia and also in the case of other symptoms. The blood pressure computer consists of precision-made electronic components. The measuring accuracy and life of the computer depend on the care with which it is treated: - Protect the computer from shocks and be careful not to drop it, - Protect it against moisture, dirt, wide fluctuations in temperature and the direct rays of the sun,15

- Do not use it in areas where there are strong electromagnetic fields, i.e. keep it away from transmitters and mobile phones.

• Do not press buttons without the cuff fitted.

• Use the computer only on persons for whose wrist size the computer is intended.

• If the computer is not used for a lengthy period of time, it is advisable to remove the batteries.

• Keep the batteries out of reach of children. Batteries do not belong in domestic waste.

• Dispose of batteries at the appropriate collection points.

• Do not open the computer. Failure to comply invalidates the warranty. You must not adjust or repair the computer yourself or its correct function will no longer be guaranteed.

• This unit is in line with European Standard EN60601-1-2 and is subject to particular precautions with regard to electromagnetic compatibility (EMC). Please note that portable and mobile HF communication systems may interfere with this unit. For more details, please contact customer service at the address indicated.

3. Table for classification of blood pressure values

(unit of measurement mmHg) for adults: Range Systolic Diastolic Action Hypotonia lower than 105 lower than 60 Check with doctor (degraded blood pressure) Normal range between 105 and 120 between 60 and 80 Self check Pre-hypertensive between 120 and 140 between 80 and 90 Check with doctor blood pressure range* High blood pressure between 140 and 160 between 90 and 100 Consult your doctor – degree I High blood pressure higher than 160 higher than 100 Consult your doctor – degree II (*) Blood pressure range that might transfer to high blood pressure Adapted from JNC 200316

4. Device description:

A. Name of the parts Setting button LCD display Start-/Stop-button Recall memory button Wrist cuff Figure No. 1 Alkaline Battery UM-4 (AAA) 1.5 V x2 Function button Carrying case17 B. Description of display symbols Afternoon time Measuring Blood pressure unit Battery weak display Error symbol Memory record Pulse-Symbol Systolic rate Diastolic rate Pulse rate Month Date Hour Minute Figure No. 218

5. Changing batteries

Remove the battery cover at the lower side of the unit and insert batteries into the battery compartment as shown, taking extreme care that the polarities + and - are observed.

6. Attaching pressure cuff

A. Wrap the pressure cuff around the left wrist. a The display of the unit should be placed on the palm side of the wrist. b Ensure that the wrist is unclothed. B. Fasten the pressure cuff snugly. a Close the cuff with the Velcro fastener, so that the top margin of the computer is about 10 mm below the ball of the thumb. b Do not pull strongly on the pressure cuff. Do not make the pressure cuff too tight. Figure No. 3 Figure No. 4 Figure No. 4-119

7. Correct measurement position

lt is extremely important for the measured values, that the cuff is at the same height of the heart. Higher or deeper position will give deviations from the true value. Measurement while sitting down: a Place your elbow on a table or other object. b Use the armrest to position the arm so that the pressure cuff is at the same height as the heart. c Relax your hand with the palm facing up. Do not talking or moving during measurement. Figure No. 5

8. Description of display mark

Mark appears in the measurement condition when pulse is detected. Appears when the battery voltage is excessively low. Measurements in progress remain quiet. Replace all two batteries by new ones. Insert the batteries at correct positions beware of the +/- directions. Display mark Condition/Cause Action Replace batteries20 Appears when the accurate blood pressure could not be obtained accurately. Press “start/stop“ button again and re-measure. Or check cuff if wrapped at the wrist or according to instructions. Check palm if exerting effort. Check if talking or moving during measurement. Check if posture is incorrect. Appears all the time till the measurement being com- pleted. Measuring error Measuring blood pressure symbol Display mark Condition/Cause Action

A. Inserting batteries in position: a Open battery cover. b Refer to the picture in positioning batteries. (Figure No. 3) c All LCD segments appear on the display in 3 seconds. d Display 1 month, 1 date, 12 hour, 0 minute. B. Setting Date and Time: a Press MODE button (“month“ starts flashing). Press SET button to set the correct month (1,2,3,... 12). b Press MODE button again (“date“ starts flashing). Press SET button to set the correct date. c Press MODE button again (“hour“ starts flashing). Press SET button to set the correct hour in 12-hour format. The time is being displayed in 12-hour format, which means a time from 13:00 onwards is being displayed as 01p:00. d Press MODE button again (“minute“ starts flashing).21 Press SET button to set the correct minute (0,1,2,3,... 59). e Press MODE button again to switch to normal time. (month, date, hour and minute appear on the display). C. Steps to take blood pressure measurement: a Wrap the cuff around the wrist (Refer to Wrapping of Wrist cuff as (Figure No. 4 and 4-1). b Sit upright on the chair to have correct posture. (Refer to Correct Posture in Taking Blood Pressure as (Figure No. 5). c First, select the memory place (No1, No2 or No3) with the Set key. Then press the Start/Stop key. After the self-test showing the complete dis- play, the device automatically shows the selected memory place once again and then starts the measurement automatically. The air pressure increases to 195 mmHg, and if there is a tendency towards high blood pressure, the air pressure is increased automatically to the required level. Do not move or talk during the measurement. If you are carrying out repeat measurements, please ensure that you have always selected “your“ personal user memory. d After the cuff pressure is increased, it will slowly decreased. When the pulse rate is detected, HEART RATE symbol will start flashing. e After taking blood pressure measurement, the Systolic rate, Diastolic rate will be lasting flash on the display for 1 minute. f You can interrupt measurement at any time by pressing the "START/ STOP" button. D. Storing, recalling and erasing measurement data: a Storing data: After every blood pressure measurement, the systolic pressure, diastolic pressure, pulse rate and the time and date of the respective measure- ment are stored automatically in the previously selected user memory. When more than 30 measurements are stored, the oldest ones are lost. b Recalling data: Press the “MEMORY“ key and select the desired user memory 1, 2 or 322 with “SET“. The number of stored data sets of this user memory appears below on the right. The average of all readings saved is shown by pres- sing the “MEMORY“ key. Press “MEMORY“ again and the last recorded values appear. You leave the memory mode with the Start/Stop key. The device switches off automatically after 1 minute. c Erasing data: (1) Take out the batteries and then refill 2 pcs batteries again. (2) To discontinue if the data is erased. Press “RECALL“ button, no data should show up on the screen. E. To change batteries: When “ “ show up on the display, the battery is weak. Change the batteries or it will not be possible to take blood pressure measurement. Used batteries do not belong in the household waste. You are legally obliged to dispose of the batteries. Dispose of them via your specialist elec- trical supplier or local collecting point for recyclable waste. Note: Batteries containing pollutant substances are marked as follows: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Battery contains mercury.

• Clean your blood pressure computer carefully only with a slightly moistened cloth.

• Do not use detergents or solvents.

• On no account must you immerse the computer in water, otherwise liquid can enter it and cause damage. Pb Cd Hg23

Model No. SBM 06 Method of Measurement Oscillometric (non invasiv blood pressure measurement at the wrist) Range of Measurement Pressure 0-300 mmHg, pulse 40-199 beats/minute Accuracy of the pressure reading systolic ±3 mmHg / diastolic: ±3 mmHg / pulse: ±5% of the displayed value Measuring uncertainty max. permissible standard deviation according to clinical testing: systolic: 8 mmHg / diastolic: 8 mmHg Sets of Memory 3 x 30-set Unit Dimension L72 x W72 x H29 mm Unit Weight Approx. 140 g Cuff Size Wrist circumference approx. 135-195 mm Operating Temperature +10 °C to +40 °C, < 85% RH Storage Temperature -20 °C to +50 °C, < 85% RH Power Supply 2 x 1,5 V Micro (Alkaline Typ LR 03) Battery Life 250 times measurement Accessories Carrying case, instruction manual, 2 pcs “AAA” battery Classification Application part Type BF Key to symbols: Application part Type BF Important! Read the operating instructions These specification are subject to change without notice for purpose of improvement.

Please dispose of the device in accordance with the directive 2002/96/EG – WEEE (Waste Electrical and Electronic Equipment). If you have any que- ries, please refer to the local authorities responsible for waste disposal.24